Senior Manager, Clinical Study Lead - Remote

Overview

Regeneron is seeking a dynamic and experienced Senior Clinical Study Lead (CSL) to spearhead the execution of complex clinical trials on a global, regional, or country level. This role demands a high degree of independence and strategic leadership, as the Senior CSL will oversee all phases of clinical trials—from study design through execution to close-out—ensuring adherence to timelines, budgets, and quality standards.

In Short

• Lead cross-functional study teams and oversee clinical trials.
• Provide operational input into protocol development and essential study documents.
• Manage international/local trials and ensure compliance with global regulatory requirements.
• Conduct risk assessments and oversee vendor management.
• Monitor progress for site activation, patient recruitment, and data entry.
• Ensure data quality through regular reviews and maintain audit readiness.
• Identify and implement innovative approaches to trial execution.
• Contribute to the enhancement of clinical trial management SOPs.
• Work on high-profile projects that advance groundbreaking therapies.
• Foster innovation and continuous process improvements in clinical trial operations.

Requirements

• Bachelor’s degree with a minimum of 8 years of relevant industry experience.
• Exceptional interpersonal and leadership abilities.
• Advanced knowledge of trial management systems and MS Office applications.
• Deep understanding of ICH/GCP guidelines and regulatory requirements.
• Advanced skills in risk assessment and budget management.
• Line management experience preferred.

Benefits

• Comprehensive benefits including health and wellness programs.
• Fitness centers and equity awards.
• Annual bonuses and paid time off for eligible employees.
• Inclusive and diverse culture.
• Opportunities for career growth and meaningful scientific advancements.